official transcript of proceedings nuclear regulatory ... · 3 appreciation. 4 vice chairman...

Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION Title: Advisory Committee on the Medical Uses of Isotopes Docket Number: N/A Location: Rockville, Maryland Date: March 8, 2018 Work Order No.: NRC-3567 Pages 1-80 NEAL R. GROSS AND CO., INC. Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433

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NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

UNITED STATES OF AMERICA 1

NUCLEAR REGULATORY COMMISSION 2

+ + + + + 3

ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES 4

+ + + + + 5

MEETING 6

+ + + + + 7

THURSDAY, 8

MARCH 8, 2018 9

+ + + + + 10

The meeting was convened in room T2B3 of 11

Two White Flint North, 11545 Rockville Pike, 12

Rockville, Maryland, at 8:34 a.m., Philip Alderson, 13

ACMUI Chairman, presiding. 14

MEMBERS PRESENT: 15

PHILIP O. ALDERSON, M.D., Chairman 16

VASKEN DILSIZIAN, M.D., Nuclear Cardiologist 17

RONALD D. ENNIS, M.D., Radiation Oncologist 18

DARLENE F. METTER, M.D., Diagnostic Radiologist 19

MICHAEL O’HARA, Ph.D., FDA Representative 20

CHRISTOPHER J. PALESTRO, M.D., Nuclear Medicine 21

Physician 22

JOHN J. SUH, M.D., Radiation Oncologist 23

LAURA M. WEIL, Patients’ Rights Advocate 24

PAT B. ZANZONICO, Ph.D., Vice Chairman 25

2


NON-VOTING MEMBERS PRESENT: 1

RICHARD GREEN 2

ZOUBIR OUHIB 3

MEGAN SHOBER 4

5

NRC STAFF PRESENT: 6

MARC DAPAS, Director, Office of Nuclear 7

Materials Safety and Safeguard (NMSS) 8

LINDA HOWELL, Acting Deputy Director, Division 9

of Materials Safety, Security, States, and 10

Tribal Programs (MSST) 11

DOUGLAS BOLLOCK, ACMUI Designated Federal 12

Officer 13

SOPHIE HOLIDAY, ACMUI Alternate Designated 14

Official and ACMUI Coordinator 15

MARYANN AYOADE, NMSS/MSTR/MSEB 16

JENNIFER BISHOP, R-III/DNMS 17

RUSSELL CHAZELL, SECY/RAS 18

SAID DAIBES, Ph.D., NMSS/MSST/MSEB 19

LISA DIMMICK, OEDO 20

SARA FORSTER, R-III/DNMS 21

ROBERT GALLAGHAR, R-I/DNMS 22

MICHELLE HAMMOND, R-IV/DNMS 23

LATISHCA HANSON, R-IV/DNMS 24

PATRICIA HOLAHAN, Ph.D., NMSS/DRM 25 NRC STAFF PRESENT (CONT.): 26

3


VINCENT HOLAHAN, Ph.D., NMSS/MSST 1

ESTHER HOUSEMAN, OGC/GCLR/RMR 2

DONNA-BETH HOWE, Ph.D., NMSS/MSST/MSEB 3

KEVIN NULL, R-III/DNMS 4

PATTY PELKE, R-III/DNMS 5

GRETCHEN RIVERA-CAPELLA, NMSS/MSST/MSEB 6

DIANE SIERACKI, OE/CRB 7

ZAHID SULAIMAN, R-III/DNMS 8

KATHERINE TAPP, Ph.D., NMSS/MSTR/MSEB 9

IRENE WU, NMSS/MSST/MSEB 10

SHIRLEY XU, NMSS/MSST/MSLB 11

12

MEMBERS OF THE PUBLIC PRESENT: 13

DAVE ADLER, American Society of Radiation 14

Oncology (ASTRO) 15

ROBERT DANSEREAU, New York State Department 16

of Health 17

MIGUEL DE LE GUARDIA, Cook’s Children Medical 18

Center 19

LYNNE FAIROBENT, unaffiliated 20

CAITLIN KUBLER, Society of Nuclear Medicine 21

and Molecular Imaging 22

MELISSA MARTIN, American Association of 23

Physicists in Medicine (AAPM) 24

RICHARD MARTIN, AAPM 25

MEMBERS OF THE PUBLIC PRESENT (Cont.): 26

MICHAEL PETERS, American College of Radiology 27

4


JOSEPHINE PICCONE, unaffiliated 1

A. ROBERT SCHLEIPMAN, Partners Healthcare 2

CINDY TOMLINSON, ASTRO3

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1

AGENDA 2

Page 3

Welcome............................................6 4

Special Presentation to Dr. Zanzonico 5

Mr. Dapas....................................6 6

Emerging Technologies Commission Paper 7

Ms. Wu......................................12 8

Administrative Closing. 9

Ms. Holiday.................................21 10

Thoughts on Leaving the ACMUI 11

Dr. Zanzonico...............................28 12

Open Forum 13

Ms. Dimmick.................................47 14

Adjourn...........................................80 15

16

17

18

19

20

21

22

23

24

25

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1

P-R-O-C-E-E-D-I-N-G-S 2

(8:34 a.m.) 3

MR. BOLLOCK: Good morning everyone and 4

thanks to Dr. Alderson. We'll kick off the second day 5

of the ACMUI Meeting. 6

To begin the day we will start with a 7

special presentation to Dr. Zanzonico from Mr. Marc 8

Dapas, our Office Director in the Office of Nuclear 9

Material and Safeguard. 10

MR. DAPAS: Thanks, Doug. Boy, I 11

appreciate the opportunity to spend a few moments here 12

in paying a tribute to the services of Dr. Zanzonico. 13

Let me just highlight a couple of things 14

regarding the contributions that you have made to this 15

group over the time that you've served as a member of 16

the ACMUI. 17

You began service on the ACMUI in March of 18

2010. You were renewed for a second term in 2014 and 19

then appointed as the ACMUI Vice Chairman in October 20

of 2015. 21

And Dr. Zanzonico has briefed the 22

Commission during a number of Commission and ACMUI 23

meetings on several occasions. Starting out in 24

October of 2013, I know you talked to the Commission 25

7


about ACMUI’s comments on the expanded Part 35 1

rulemaking. 2

And then have had quite a bit of 3

involvement with the patient release of project. Back 4

in May of 2014, you presented the ACMUI’s position on 5

patient release and then in March of 2016, I 6

understand that you provided ACMUI’s comments on the 7

patient release project and the activities of the NRC. 8

And then today, as I understand it, at the 9

Commission meeting this morning, you will be 10

discussing the ACMUI’s comments on our recommendations 11

for revisions to the patient release program. And I 12

signed the Commission paper that was provided, 13

recommending that we, or indicating that we plan to 14

update guidance versus pursue rulemaking for patient 15

release. 16

And I appreciate very much the ACMUIs 17

engagement on that important topic. The topic of 18

considerable stakeholder interest. And thank you, 19

Dr. Zanzonico, I hope I'm pronouncing that correctly -20

- 21

VICE CHAIRMAN ZANZONICO: That's fine. 22

MR. DAPAS: -- for your involvement in 23

that effort. 24

Clearly you are recognized for your 25

8


expertise in the field of medical physics and nuclear 1

medicine, and as a result of that recognized expertise 2

you had the opportunity to serve as vice chairman. 3

You also served on the speaker panel for 4

the NRC medical issues workshop in June of 2011. And 5

during your time on the ACMUI you have, the staff has 6

benefitted from your expertise on a number of high 7

priority issues. 8

Including the review of the hormesis 9

linear no threshold petitions for rulemaking. And 10

it's my understanding there was a meeting most 11

recently on the National Council on Radiological 12

Protection earlier this week where they talked about 13

the linear no threshold model. 14

But certainly appreciate your views 15

regarding our actions to consider whether we wanted to 16

pursue rulemaking with respect to that model. 17

The advanced notice of proposed rulemaking 18

on potential changes to radiation protection 19

regulations embodied in Part 20. You've been involved 20

in providing your perspective on the release of 21

patients administered radioactive materials, as I 22

mentioned. 23

And then revisions to NUREG-1556 Volume 9, 24

which is consolidated guidance about materials, 25

9


licenses and program specific guidance about medical 1

use licenses. 2

And then Part 35.1000, dealing with 3

licensing guidance for Germanium-68 and Gallium-68 4

generators, in the impact of decommissioning funding 5

plan requirements on the use of those particular 6

generators. 7

And then finally, we have benefitted from 8

your expertise on nursing mother guidelines for the 9

medical administration of radionuclides. I think 10

there was a subcommittee report out on that earlier 11

this week in a public meeting with folks participating 12

via phone on that matter. 13

And you also served as chair to five 14

subcommittees including ACMUI bylaws, licensing of 15

Radium-223 Dichloride, Germanium-68/Gallium-68 16

generator licensing guidance, as I mentioned. 17

And both the proposed rule and final rule 18

for the medical use of byproduct material. Meaning, 19

medical event definitions, training and experience and 20

clarifying amendments in Parts 30, 32 and 35. 21

And I know, from my time in the regional 22

office and then of course my time here in NMSS, there 23

has been a lot of engagement on medical event 24

definitions in the brachytherapy as well as training 25

10


and experience requirements. 1

And I appreciate the efforts of the ACMUI 2

in looking at the competency modeling versus just the 3

hours approach and we look forward of course to the 4

Committees views on how to proceed with respect to 5

that. And your willingness to look at various 6

modalities in determining what are the appropriate 7

training and experience requirements. 8

But I would like to, at this time, take 9

the opportunity to just present you with a few items 10

to express our appreciation and gratitude for your 11

eight years of dedicated service, Dr. Zanzonico. And 12

thank you, again, for all the input that you've 13

provided. 14

I do view this committee as a very 15

important aspect to our process and that the input you 16

provide, the perspectives that you offer certainly 17

help to shape our approaches to the regulatory 18

products that we provide. And we very much value the 19

expertise on this Panel. 20

And that expertise is particularly 21

embodied with the efforts and perspective that you've 22

offered over your eight years of involvement, 23

Dr. Zanzonico. So with that, let me first begin with, 24

and please feel free to come up here. 25

11


What I first would like to present you 1

with this gold lapel pin. That's just a token of our 2

appreciation. 3

VICE CHAIRMAN ZANZONICO: Thank you very 4

much. 5

MR. DAPAS: Hopefully you might want to 6

wear it at the Commission meeting. 7

(Laughter) 8

MR. DAPAS: And I gladly present you with 9

this certificate of appreciation honoring Pat D. 10

Zanzonico PhD in recognition of eight years of service 11

in leadership to the Advisory Committee on the medical 12

uses of isotopes which resulted in significant 13

contributions to the work of the U.S. Nuclear 14

Regulatory Commission, dated March 1st, 2018, signed 15

by Kristine L. Svinicki, Chairman of the NRC. So, 16

congratulations. 17


much. 19

(Applause) 20

MR. DAPAS: Let me present to you this 21

certificate that's a flag of the United States of 22

America. This is to certify that the accompanied flag 23

was flown over the United States Capitol on February 24

9th, 2018 at the request of the Honorable Chris Van 25

12


Hollen, United States Senator. This flag was flown 1

for Pat D. Zanzonico PhD, in honor of your retirement 2

after eight years of federal service. So we present 3

you with this flag and certificate. 4


much. 6

MR. DAPAS: Congratulations. 7

(Applause) 8

MR. DAPAS: Flag in front of a flag. 9

(Laughter) 10

MR. DAPAS: Thank you for the opportunity 11

to make that presentation and look forward to hearing 12

the remarks that you'll have with the Commission later 13

this morning. 14

And again, I really do very much 15

appreciate the expertise in the input that you provide 16

because they really play an important role in 17

determining what is the best regulatory approach going 18

forward and how you represent the medical community 19

and the patients' rights advocate and how important 20

that is. So thank you for that and I hope you enjoy 21

the rest of your meeting and we'll see you in the 22

Commission hearing room here shortly. So thank you. 23

(Off record comments) 24

MS. WU: This is a tough act to follow so 25

13


I will move on to the next topic. All right, so I'm 1

Irene Wu, I'm with, I'm a project manager here at the 2

NRC and I'm happy to be able to talk to you today 3

about the Emerging Medical Technology's Commission 4

paper. 5

I had hoped to be able to give you more 6

information and give you a more heavier presentation 7

than what I have in the slides for you today, but 8

unfortunately the paper right now is still in 9

concurrence so everything is still pre-decisional. 10

And we are hoping that it goes to the Commission 11

within the next few weeks. 12

But in the meantime, I'm happy to give you 13

an overview of what the paper covers and give you a 14

general feel of what it will hopefully be when it 15

comes out. 16

MR. DAPAS: I just have to offer one 17

comment. I've reviewed the paper and incorporated my 18

comments and hopefully in the next few weeks it will 19

go up -- 20

MS. HOLIDAY: Thank you, Marc. 21

MS. WU: Thanks, Marc. Okay, so the 22

purpose of the paper is to provide the Commission with 23

the NRC staff’s review of the emerging medical 24

technologies program. 25

14


So it is an information SECY paper. And 1

it also serves another purpose in forming the budget 2

formulation process here. 3

We seem to be always going through budget 4

formulation here and working on the future, so to 5

inform 2020 and beyond and help inform that. Again, 6

this is a staff generated paper, it is not an SRM 7

directive paper. 8

So general content and feel for the paper, 9

again, this, it does provide a general process for how 10

we review emerging medical technologies. So as you 11

know, we get a lot of input from various stakeholders, 12

such as yourselves, FDA, manufacturers of these 13

technologies and Agreement States. 14

In the cases where we do our review and 15

the medical technologies don't necessarily fall under 16

a specific modality and we determine that it falls 17

under a 35.1000, we'll form an NRC agreement state 18

working group. 19

And so the paper kind of highlights that 20

general process. It also discusses, includes a brief 21

discussion of the past in process and anticipated 22

future reviews of medical technologies. 23

So if you've seen the medical, the NRC 24

medical uses licensee's tool kits, we have a list of 25

15


the past reviews that we have done with links to the 1

specific licensing guidance. The paper will also 2

include some of the ones that are currently in 3

process. 4

And then again, based on different input 5

from different stakeholders, what we think we might be 6

getting in the future years. 7

And then there will be a nonpublic 8

enclosure that has resource estimates for the review 9

of new technology and guidance development, and those 10

resource estimates are based on what we've done in the 11

past and what the resource utilization has been. And 12

again, sort of crystal balling it, when we think the 13

review might be coming to the NRC. 14

So, I've just listed a few examples of 15

some past reviews that we've done. And again, this is 16

on the NRC medical uses licensee toolkit website. 17

The first two I believe are both, both 18

resulted in 35.1000 licensing guidance. And the last 19

one fell under one of the individual modalities, but 20

on the website, we did document our licensing decision 21

through a memorandum to the regions. 22

So some examples of in-process reviews. 23

And these were touched upon yesterday at the meeting. 24

Yttrium-90 Microspheres, the Leksell Gamma Knife® 25

16


Perfexion™ and Icon™. And then also the Lutetium-177 1

dotatate. 2

So the first two we are working on updates 3

to the 35.1000 licensing guidance. And the last one 4

will likely result in a memo to the regions. 5

And then, again, these lists aren't 6

complete of what's going to be in the paper itself, 7

but I did want to show a few of the anticipated 8

reviews that we see coming in FY2020, FY2023. Again, 9

the list will be more comprehensive in the paper. 10

So those include Phosphorus-32 OncoSil 11

miroparticles, the MASEP Infini cobalt-60 stereotactic 12

radiosurgery and the GammaPod cobalt stereotactic 13

radiotherapy. 14

So as I mentioned before, sort of the next 15

steps is the paper, is going through our internal 16

concurrence process. We hope that it gets to the 17

Commission sooner rather than later. 18

And typically, once the paper is up to the 19

Commission it takes about two weeks before it gets 20

released to the public. And we can make sure that we 21

get a copy to the ACMUI and also really, you know, 22

send it via our medical list serve and make sure it's 23

out there. 24

So I think that everything. 25

17


CHAIRMAN ALDERSON: Comments? Dr. 1

Zanzonico. 2

VICE CHAIRMAN ZANZONICO: How is it 3

decided or what's the mechanism for choosing, if 4

that's the right word, what new technologies to 5

address in guidance or otherwise? 6

Is it just through licensee applications 7

or is there some other mechanism for this sort of 8

thing? 9

MS. WU: Do you want to field that? 10

MR. BOLLOCK: Yes, I can field that. This 11

is Doug Bollock. 12

So when the NRC receives, sometimes it is 13

through a license amendment the NRC will receive 14

information on a new drug, a new technology, 15

something. If it's something that hasn't been 16

licensed before, typically the regions or sometimes 17

the States, will contact our group. 18

And we just look, the first look is, does 19

this drug, does this technology, fit into one of the 20

modalities in 35.300, Sections D to L. So, is it 21

under, can it already be licensed under 100, 200, 300, 22

400, 600. 23

If I cannot be licensed under one of those 24

for whatever reason, there is a part of the system, 25

18


specifics of the system that are, either aren't 1

directly addressed or it's, would not be able to meet, 2

some specifically would not be able to meet one of 3

those sections, then we have to, then if it falls 4

under the 35.1000 regulation and we have to come up 5

with the specific license conditions. 6

And that's what we develop, we call it the 7

licensing guidance but really it's guidance to our 8

license reviewers with specific license conditions we 9

deem, the NRC deems necessary for the safe use of the 10

technology. So yes, it has to not fit in a section 11

that's already there for us to develop the technology. 12

MS. HOWELL: Yes, so it's not so much a 13

matter of us electing which radiopharmaceuticals 14

treatment modalities we're going to look at or not 15

look at, it's a matter of the various mechanisms that 16

bring that new technology to us. And it could be an 17

agreement state, getting an application for an SSND 18

review, it could be through any of the professional 19

organizations with the manufacturer coming out with a 20

new radiopharmaceutical. 21

But if Doug's group screens it and it 22

doesn't fit into the existing sections of Part 35, 23

then it goes through the new licensing guidance 24

development. Very similar to what Dr. Howe did 25

19


recently with the new molytech generators. 1

MS. HOLIDAY: If I could add on to that. 2

This is Sophie Holiday. 3

Some of the members on the Committee may 4

recall a few years ago I gave a presentation that 5

spoke exactly to this point about, how does NRC 6

determine if an emerging medical technology is 7

licensed under 35.1000, it encompasses everything that 8

both Mr. Bollock and Ms. Howell just stated for you. 9

And I'll be happy to send those slides back out to 10

Committee as well. 11

CHAIRMAN ALDERSON: Are there any further 12

questions? Yes. 13

MR. OUHIB: Yes. Is there a prerequisite 14

regarding the FDA for instance or is that possible 15

that it's in the process? 16

In other words, does it have to be 17

approved first before actually NRC will look into 18

that? 19

MR. BOLLOCK: No. However, we tend to, we 20

don't like to get ahead of the FDA. And then if it's 21

something the FDA is reviewing we don't share that 22

information with the public. 23

So those few examples that we had, we've 24

publicly received that information about things that 25

20


are coming out in the future, that's why we're able to 1

share that. But we, in our memorandum of 2

understanding with the FDA, we do not share that 3

proprietary information that the FDA has. 4

So we will, as with the NorthStar, that 5

was pretty public that NorthStar was, they publicly 6

announced that they were putting out this new 7

technology, they came to our public meetings and said 8

it, so we were doing it at the same time in parallel 9

with, we were conducting our view parallel with the 10

FDA. 11

That is typical, but, yes, we tend to lag 12

the FDA because they can make significant changes to 13

designs of these technologies or adjustments to the 14

drugs that we would change, could possibly change if 15

we have to review. And they are a lot more, typically 16

more stringent if they do a much broader and deeper 17

look. 18

We look at the radiation safety aspects 19

and the licensing and inspection aspects of it. From 20

our perspective. 21

CHAIRMAN ALDERSON: Mr. O'Hara. 22

MEMBER O'HARA: Yes. The GammaPod was 23

recently cleared. As a matter of fact, there was a 24

press release from the FDA because of the unique 25

21


nature of the GammaPod. And we do, usually we work 1

closely with the NRC on these issues for new devices. 2

CHAIRMAN ALDERSON: Yes, Ms. Weil. 3

MEMBER WEIL: Thank you. We won't see any 4

of this information until it's public, is there 5

nothing that the Members of this Committee who use 6

these technologies could offer in the pre-decisional 7

process while we are reviewing stuff? 8

MR. BOLLOCK: Staff actually does, on 9

occasion, reach out to Members of the ACMUI or medical 10

consultants as need for specific technologies in 11

helping us review that. 12

One of the examples was, with the 13

Germanium/Gallium generators, I know we reached out to 14

the previous nuclear pharmacist from the ACMUI and, 15

yes, yes, we reached out. He is a, as an ACMUI member 16

then we kept him on as a medical consultant. 17

So we do reach out to ACMUI members in 18

helping us review. And then of course most of these 19

technologies, and all of the initial reviews of 20

technology, we do share with the ACMUI and seek ACMUI 21

input. 22

CHAIRMAN ALDERSON: Other questions or 23

comments? Seeing none, thank you. 24

So we are well ahead of schedule. And we, 25

22


our next activity listed on the agenda is a break and 1

then the Commission meeting. So -- 2

MS. HOLIDAY: Dr. Alderson, this is 3

Sophie. If I may, as we've done in the past, when we 4

have been significantly ahead of schedule, my 5

suggestion is, is it possible, would the Committee 6

entertain my doing the administrative closing portion 7

of the meeting where we can provide some tentative 8

dates for the fall meeting? 9

CHAIRMAN ALDERSON: Right. Unless I hear 10

objection to that, and I see none, that's fine, you 11

can go ahead with that. 12

MS. HOLIDAY: Okay. So, for all of the 13

members on the Committee, I provided a meeting doodle 14

to the membership to provide tentative dates for the 15

fall ACMUI meeting. Again, our fall meeting occurs in 16

either September/October. 17

I had 11 responses, and not surprising, I 18

didn't get one set of dates where 11 people were 19

available. However, the date that had the most 20

promise was September 20th and 21st. 21

The only member that had indicated they 22

were not available was Dr. Ennis. Are there other 23

Members that are not available on September 20th and 24

21st? 25

23


CHAIRMAN ALDERSON: We're checking. I 1

don't see anyone saying they're not available. 2

MS. HOLIDAY: Okay. So I would like to 3

propose that we set September 20th and 21st as our 4

first option for the fall meeting. So now we'll have 5

to pick our backup dates. 6

Interestingly enough, I have three sets of 7

dates where nine out of 11 responded were available. 8

However, of the three sets of dates, our new ACMUI 9

Chairman will not be available for two of those 10

meeting dates. 11

But the third date where he is available, 12

our current presiding ACMUI Chairman, Dr. Alderson, is 13

not available. And his, the person who we have 14

selected, Dr. Schleipman, to take on the new Health 15

Care Administrator position, assuming that he has 16

received his clearance and was able to be a full 17

voting member, is also not available. 18

So I'll just throw out the three sets of 19

dates. The first set is September 17th and 18th. 20

Both Dr. Ennis and Dr. Palestro indicated that they 21

were not available. 22

Then there is October 4th and 5th, again 23

Dr. Ennis and Dr. Palestro are not available. And 24

then the last set is October 10th and 11th where both 25

24


Dr. Alderson and Dr. Schleipman are not available. 1

So, I will now leave this most important 2

backup date decision to the Committee for discussion. 3

(Off microphone comment) 4

MS. HOLIDAY: Yes, ma'am. The first set 5

of dates for alternative, they're tentative second 6

choice, is September 17th and 18th, the second set is 7

October 4th and 5th and the last is October 10th and 8

11th. 9

MEMBER ENNIS: I can do October 4th and 10

5th. Though I had indicated -- 11

MS. HOLIDAY: Okay. 12

CHAIRMAN ALDERSON: Microphone. 13

MEMBER ENNIS: Oh, sorry. I could do 14

October 4th and 5th, so if I indicated otherwise 15

that's not correct. 16


MR. GREEN: Sophie, with the change of 18

folks in certain roles and certain people unable to 19

attend, are you having a problem getting a quorum? 20

MS. HOLIDAY: I'm not having a problem 21

getting a quorum because as you know, for a quorum we 22

have to have, sense there are only ten current voting 23

members, to have a quorum I need to have six. And 24

this wouldn't impact the six, there are just 25

25


considerations that, you know, for one, do we mind 1

having our new chairman not present for the meeting, 2

in which case the Vice Chairman can still preside as 3

acting Chairman -- 4

(Off microphone comment) 5

(Laughter) 6

MS. HOLIDAY: I understand. The other 7

consideration would be, if this will be Dr. Alderson's 8

last meeting, like I said, assuming that Dr. 9

Schleipman is able to obtain his security clearance, 10

we would not be able to do out proper special fair 11

well presentation to Dr. Alderson. Yes, Dr. Ennis. 12

MEMBER ENNIS: Well it seems pretty clear 13

we should do the date that I'm the only one who cannot 14

attend since I'm less vital than the people going off. 15

I may be able to make it, it's in my holiday season, 16

as you can kind of see from the schedule. 17

MS. HOLIDAY: Yes. 18

MEMBER ENNIS: And even though those are 19

not actual holiday days, I still have personal stuff 20

that needs to kind of get done that I may not be able 21

to do if I were to come to the meeting, so I will 22

figure out whether I can come for part or all the 23

meeting or not. But if I am the only one and the 24

chairs and vice chairs are all available on those 25

26


dates, it's pretty clear that we should stick with 1

that date. 2


MEMBER PALESTRO: So, excuse me? 4

MS. HOLIDAY: Yes. 5

MEMBER PALESTRO: I don't remember the 6

poll at this point, there is nothing -- 7

CHAIRMAN ALDERSON: Microphone please. 8

MEMBER PALESTRO: Yes, this is Dr. 9

Palestro. I don't remember the poll at this point but 10

there was nothing after the middle of October? Okay. 11

MS. HOLIDAY: There is not. So as you can 12

see on our calendar here, the ASTRO Meeting takes 13

places October 22nd through 24th then several of the 14

members, we wouldn't have a quorum for the remaining 15

dates on the month. 16

MEMBER PALESTRO: And the best of these 17

three dates, for second choice for me, would be 9/17 18

and 18. If that's what it comes down to, I'll just 19

rearrange my schedule. 20


MEMBER ENNIS: So, 9/18 is a definite, 22

that's really not, I can probably come for the 23

Thursday the 20th. If we do the 20th and the 21st I 24

could probably, I could be here for the 20th. I don't 25

27


think I can stay for the 21st except maybe a very 1

short time in the morning. 2

MS. HOLIDAY: Okay. So I think September 3

20th and 21st still remains the Committee's first 4

choice, but so for the second choice it sounds like 5

our second choice will be September 17th and 18th. 6

We'd still be in the same boat in terms of not having 7

Dr. Ennis. 8

Also remembering that our fall meeting is 9

when your subcommittee does their medical events 10

presentation, so that means he may delegate that to 11

anyone of you lucky members on the Committee. 12

So, I guess at this time I'd like to 13

confirm with the Committee. Our first choice for the 14

fall meeting will be September 20th and 21st and our 15

second choice will be September 17th and 18th. Is 16

there a consensus amongst the Committee Members? 17

CHAIRMAN ALDERSON: It seems as if there 18

is, no one is objecting. 19

MS. HOLIDAY: Great. Thank you very much. 20

CHAIRMAN ALDERSON: All right, is there 21

anything else we can bring forward? 22

MS. HOLIDAY: I do not believe so. 23


MS. HOLIDAY: After, since the Commission 25

28


meeting doesn't start until 10 o'clock, we were going 1

to take a break at 9:30 because that would give the 2

Committee enough time to travel to the commission 3

hearing and get settled. 4

After the Commission meeting concludes, of 5

course there is the group photo with the Committee 6

Members and the Commission, we break for lunch. 7

And when we come back from lunch, the only 8

items on the agenda are Dr. Zanzonico's fair well 9

remarks, open forum and then the administrative 10

closing portion where I go over any new 11

recommendations or actions that have occurred during 12

the course of this two day meeting. 13

So we have 23 minutes before the 9:30 14

meeting, the Committee may either take a much longer 15

extended break or if Dr. Zanzonico would like to make 16

his remarks. 17

VICE CHAIRMAN ZANZONICO: I'm happy to do 18

that. 19

MS. HOLIDAY: If you think you can do that 20

in 23 minutes. 21

VICE CHAIRMAN ZANZONICO: I think so. 22

(Laughter) 23

VICE CHAIRMAN ZANZONICO: Usually it takes 24

me longer than that to say hello, but -- 25

29


(Laughter) 1

VICE CHAIRMAN ZANZONICO: -- I can make an 2

exception in this case. 3

MS. HOLIDAY: Okay, very well. 4

VICE CHAIRMAN ZANZONICO: Well, thank you 5

all again. It's hard to believe it's been eight 6

years. And a lot has happened, I'm sure, to all of us 7

in that time. 8

We've had our first grandchild and we're 9

expecting our second. And a lot of other good things 10

have happened. 11

And there are a few technical sort of 12

institutional observations, suggestions, comments I 13

wanted to offer. And I wish I could say they were 14

particular insightful or novel, but none of them are. 15

But I'll say them nonetheless. 16

I think the first and foremost, having had 17

very little interaction with regulators at this level, 18

in this depth prior to my membership on the ACMUI is 19

how enormously impressed I am with the NRC staff and 20

with its dedication to its mission and their technical 21

expertise. 22

I know it comes as a shock to many people 23

in the room that many licensees and end users actually 24

think there's an adversarial relationship between 25

30


regulators and end users. And when you work with the 1

NRC staff firsthand, there's no basis for that at all. 2

I mean, it really it is a very supportive attitude to 3

advance and do all they can to not impede in any way 4

clinical care and advancement of medical science and 5

so forth. 6

And somehow the NRC needs to do a better 7

job of getting that message out that they really are a 8

facilitatory of medical practice of advancements in 9

medical care and so forth and not purely a regulator. 10

Certainly, that's their primary mission. 11

It's a necessary mission and so forth. But they need 12

to do a better job of putting a positive spin, a 13

justifiable positive spin on all they do and all they 14

have to offer. 15

And sort of a corollary of that is, given 16

the technical expertise, the very impressive technical 17

expertise available on the NRC staff, is making that 18

technical expertise in some way available to end 19

users. Especially end users that may be under-20

resourced. 21

And somehow I think the NRC should be more 22

proactive in somehow being a collaborator with 23

licensees and not simply, and we've heard this before, 24

not simply a reactive body. But again, I've been so 25

31


impressed with the technical knowledge, technical 1

expertise of really everyone on the staff. 2

And it just seems that there is so much 3

benefit to be gained from that by sharing that 4

expertise with the end user community, with the 5

licensee community. 6

The other point, and it actually segues 7

into the last presentation, on the other hand, is that 8

somehow the flexibility and the adaptability of the 9

NRC needs to be expanded, needs to be improved. 10

We saw this firsthand, the ACMUI has seen 11

this firsthand, with Xofigo and Radium-2223 12

Dichloride. Which at the time was a completely new 13

class of radiopharmaceuticals. 14

And it generated, understandably, a lot of 15

angst among the NRC and the regulator community. And 16

I think fortunately for all of us, that's just the tip 17

of the iceberg, I mean there's going to be advances in 18

theragnostics use of diagnostic therapeutic pairs for 19

personalized treatment of cancer and other diseases. 20

There's going to be increased use of 21

multimodality therapy. Johns Hopkins, for example, is 22

using radioiodine therapy in conjunction with external 23

beam radioiodine to target metastatic thyroid cancer. 24

And those sorts of combination therapies, 25

32


radiation based combination therapies are likely to 1

increase. There is certainly going to be an increase 2

in alpha particle radiation therapy. 3

We have at Memorial, trials planned with 4

pre-targeted radiotherapy using alpha particle 5

emitters and there's been very impressive reports from 6

Europe using PSMA targeted radioligand labeled with 7

alpha particle emitters. And the improvement in 8

therapeutic response with those versus Lutetium-177 9

labeled versions, you know, bank under miraculous. 10

At Memorial, we're increasingly using 11

regionally administered radionuclide therapy. For 12

example, children who have leptomeningeal disease and 13

are treated with an I-131 labeled antibody HH9, had a 14

five year survival of under ten percent. Now, those 15

same kids, after long-term follow-up, have survivals 16

of well over 90 percent. 17

And, again, leading to the alpha particle 18

radiotherapies, I think it was fortuitous that the 19

first of these was radium-223. Which among the 20

transuranics has a relative simple, a very simple in 21

fact, decay scheme. It decays to a stable daughter. 22

Most of the transuranics and most of the 23

alpha particle emitters that are being developed for 24

radionuclide therapy have much more complex decay 25

33


schemes with multiple daughters and their own 1

particular bio-distributions and so forth. And those 2

are going to present special problems. 3

The point being, there's a lot on the 4

horizon. Very new, very different applications of 5

radionuclides. And we've all seen, pretty 6

diplomatically, the very deliberate pace of 7

rulemaking. 8

And so there needs to be a more flexible, 9

a more adaptable approach to dealing with these 10

developments, other than rulemaking. Whether that 11

lies in guidance or some other mechanism. 12

These things are coming down the pike and 13

they're going to come down the pike at an accelerated 14

pace. And somehow, so as not to impede their clinical 15

implementation, there seems to be a need for an 16

accelerated pace of addressing them among the 17

regulators. 18

Another point is, I think the NRC, and in 19

turn agreement states, should leverage, to a far 20

greater extent than it does, available expertise 21

that's out there. And I'm thinking specifically of 22

documents and other resources from the ICRU, from the 23

ICRP. And in particular, the NCRP. 24

I think a lot of the issues that the NRC 25

34


wrestles with often, have been addressed in detail, in 1

various NCRP reports where they develop very 2

prescriptive guidance, model procedures and so forth. 3

And I think it would circle the NRC and the user 4

community very well, to leverage that to a greater 5

extent than they have. 6

So, those are just some kind of technical 7

observations I had. But more importantly, I wanted to 8

speak to sort of the personal level of things. 9

This has been a great experience. This 10

has been one of the greatest professional experiences 11

in my life serving on the ACMUI. I've made lifelong 12

friends among current and past members of the 13

committee and the NRC staff. 14

And several people have approached me 15

about whether this is something worthwhile to do. And 16

I have to say, when I first joined the ACMUI, said, 17

well, this is a nice thing to put on your resume and 18

this will be nice to go to a meeting or two a year and 19

just forget about it otherwise. It's a lot of work. 20

It is an enormous amount of work. 21

But it's a very gratifying work in the 22

sense that I genuinely feel that we have an impact on 23

NRC decisions and on regulations and on guidance. And 24

in that sense, it's absolutely worthwhile and I 25

35


recommend it very highly to whoever may be considered 1

for this position. 2

And I think given our locations, it's very 3

appropriate to make an analogy. Someone once asked, 4

well, would you rather be a Senator or a Congressman, 5

and they said, well, I'd rather be a Senator because 6

I'd rather be one out of 100 than one out of 400. 7

Well, here we're one out of 13, so this is 8

even a more select group and a very responsible group. 9

So it really has been a pleasure and an honor to 10

serve. I thank you all and I'll miss you all and God 11

speed. 12

(Applause) 13

CHAIRMAN ALDERSON: So, Sophie, just to 14

let other people sort of plan their day, as you look 15

at, we've really gone through the key things for the 16

afternoon sessions. We've determined the priorities 17

for meeting dates in the fall, we've heard from 18

Dr. Zanzonico, and so one wonders whether in fact 19

Members should really be planning to leave and that 20

will we really need to have an afternoon session? 21

MS. HOLIDAY: There is one presentation 22

that I told you about before that Lisa Dimmick, who is 23

our medical radiation safety team leader, wanted to 24

give a presentation to the ACMUI very briefly during 25

36


the open forum session. She wanted to be able to 1

inform the Committee and other meetings about NRCs 2

transformation innovation initiative. 3

It will only take about five to seven 4

minutes but your afternoon will essentially be very 5

short. And I, again, also need to go over any new 6

recommendations or actions that have occurred. But 7

essentially, I envision that we will be done very much 8

so before 2 o'clock. 9

CHAIRMAN ALDERSON: Yes, before 2 o'clock. 10

All right, so for anyone who needed that information 11

there you go. So, the afternoon session will conclude 12

probably within a matter of half an hour and it will 13

be done by or before 2 o'clock. So if that makes any 14

difference to people. 15

Okay, are there any other issues to be 16

brought up? We're about ten minutes ahead of our 17

typical break but we'll break and it will be time to 18

sort of go over your notes for the Commission meeting 19

and to get on downstairs. 20

MS. HOLIDAY: Unless any other Member 21

would like to make any remarks for Dr. Zanzonico? I 22

saw looks on faces. 23

CHAIRMAN ALDERSON: Okay. 24

MR. OUHIB: Yes, Dr. Zanzonico, your words 25

37


were very moving for us non, not clear yet, but scary 1

at the same time. 2

(Laughter) 3

MR. OUHIB: No, just kidding. I think you 4

put it very well. If I might add one item to the NRC 5

is really to provide, I know the ACMUI is going to be 6

reaching out to, have been, reaching out through 7

organization, been at meetings and so on and so forth. 8

I really like to see more support from the 9

NRC having NRC staff available at national meetings. 10

It is very, very useful. Because that's where things 11

will change. 12

It's the face-to-face interaction. And to 13

be comfortable, I remember a few years ago, very well, 14

whether it's a state or NRC, then whether it's a 15

speaker saying, I don't have we have an NRC 16

representative in this crowd here or a State, you 17

know, and so on and so forth. 18

But I think the more we have that 19

interaction, and I have seen it, the better people 20

feel comfortable discussing, reaching out and getting 21

clarification and not have that oppose or adversary or 22

whatever, however you want to define it, relationship. 23

And I think that's how we can make a major 24

improvement. 25

38


CHAIRMAN ALDERSON: Okay. Dr. Metter. 1

MEMBER METTER: Yes, thank you. Well, it 2

was about a year and a half ago I believe, Dr. 3

Alderson had put on a request that we go to our 4

individual societies and do just that. And it's a 5

session we call speak to the regulators, which I've 6

done with the ACR. And Dr. Palestro and I have done 7

that at SNMMI. 8

And actually, it's going to be probably a 9

regular session at our annual society meeting. And 10

it's been very well received. 11

And Doug's been there and Said's been 12

there and it's been very helpful. They've done a lot 13

of questions and it's very well received. And so I 14

think that has already taken place, at least in the 15

societies I've been involved with. 16

I also would like to thank Dr. Zanzonico. 17

You know, when you first are on this Committee and 18

you're made in charge of a Subcommittee, thank you to 19

Sophie, you get really nervous, but Sophie goes, it's 20

always the favor thing, but we'll help you. 21

(Laughter) 22

MEMBER METTER: But when Pat's on the 23

Committee I feel really, very assured. Your expertise 24

has been invaluable and thank you so much. 25

39


And I know you work very, very hard but 1

your expertise is very well, very valuable to me and 2

to the Committee. And thank you so much for all your 3

work. 4

CHAIRMAN ALDERSON: I think one thing that 5

I've heard several people say, and I really do believe 6

myself that it's true, this is a particularly good 7

group and the groups that have overlapped over these 8

last several years, on this group of 12 or 13, have 9

really been very high-quality people with great 10

expertise, very easy to work with. 11

And Pat has been one of the people whose 12

exemplified that. And it's made working on the 13

Committee a real pleasure, so, Pat, we thank you for 14

that. 15

Are there any other comments that people 16

would like to make? Yes, Mr. Green. 17

MR. GREEN: This is a two-headed question. 18

It's a question for the NRC and it's a question for 19

the professional societies. 20

I think the outreach has been great. I 21

attended the presentation at the SNMMI last year that 22

Dr. Palestro had spoke at and Dr. Metter. 23

I was wondering if the professional 24

societies at their annual meetings, SNMMI or ASTRO or 25

40


whatever, if they can make available one of those, on 1

the Exhibition Hall floor you've got the small little 2

booths that are typically rented by commercial firms 3

with a table and a drape, if they can make available, 4

or willing to make available, for the NRC to have an 5

NRC member of staff. Folks can come through that 6

Exhibit Hall and talk face-to-face with the mysterious 7

regulator that, you know, I think it would be great. 8

So it would take two part, the willingness 9

of the NRC to have someone in attendance and a place 10

for them to call home for that day or two in the 11

Exhibition Hall. 12

MR. BOLLOCK: And I can speak to a little 13

bit of that. We have, on a couple of occasions, APM 14

in particular has given us a booth a couple of years 15

ago. They, I believe they gave it to us essentially 16

for free, and it was in D.C. so we had a lot of, you 17

know, no travel costs for us so we had multiple staff 18

members there the entire two or three days. So that 19

was very good. 20

We've also, so we have rented out a booth, 21

I believe also at AAPM, two years prior to that. A 22

year or two prior to that. It had a poster to discuss 23

the draft rule for Part 35. So we have found success 24

with that. 25

41


And when Dr. Alderson started this 1

initiative to increase the communication with the 2

professional societies and the Panel for discussions, 3

we've worked very hard, staff and NRC management, to 4

prioritize the travel so that we can ascend at least 5

one of the staff to each of the major society 6

meetings. And we continue to do that. 7

As I, I think about two years ago I spoke 8

about our, we do have budget constraints. Our travel 9

budget is very small for the group that we have. I 10

mean, extremely small. 11

But, we've been successful, I believe in 12

the past two years, of getting at least one 13

representative at each of the meetings. And we will 14

continue to strive for that. 15

If there are any meetings that we are not 16

attending and you think would be worthwhile for us to 17

attend, continue to share that information with myself 18

or any of my staff and we will strive to do so. 19

But, you know, so there is the balance. 20

We have limited, very limited resources, especially 21

with travel. We've found ways to maximize, we have 22

found ways to maximize our participation and really 23

have these meetings higher priorities, as high as 24

priority as we can. 25

42


Because it's not just my group, it's the 1

division's travel budgets so I have, there are other 2

branches that are competing, right, for the little bit 3

of travel money. But we -- 4

MS. HOWELL: We do have -- 5

MR. BOLLOCK: -- have been successful. 6

MS. HOWELL: We do have the capacity to 7

have some of the senior regional staff members also 8

participate in meetings, depending on their location, 9

since we know they vary around the country. So, I 10

think the important message is to make sure that Doug 11

and his team are informed of meetings that you think 12

would benefit from our presence. 13

It's a win, win. The community that we 14

regulate gets to see us perhaps in a different 15

environment, in a different light. And we have the 16

opportunity to gather more information that is 17

currently meaningful to us in our regulatory 18

perspective. 19

MR. BOLLOCK: Yes. And we have even, we 20

tried. We think outside the box sometimes and if 21

there is a meeting in California that we can't make, I 22

know I've called into an SNMMI government affairs 23

meeting to have a good discussion with them and talk 24

about some of the topics of interest to us and answer 25

43


questions. 1

So we are willing and able to reach out in 2

any way we can and we do strive and prioritize it. 3

And as Linda said, we also have a regional 4

staff who for their training development and outreach 5

they go out to a lot of these meetings as well. So if 6

we're made aware we can coordinate with those staff 7

and they can represent us, they represent the NRC and 8

they can pass the information to my team as well. 9

And likewise, we share the, you know, we 10

like to share the information that we learned with our 11

counterparts in the regions. 12

CHAIRMAN ALDERSON: Ms. Weil. 13

MEMBER WEIL: In addition to professional 14

societies, you've sent staff, and even a commissioner 15

has gone to patient community meetings. The Thyroid 16

Cancer Survivor's Association for several years had 17

NRC staff attend and talk. 18

MS. HOLIDAY: There are two people. 19

CHAIRMAN ALDERSON: Excellent. Yes. Yes, 20

hi, coming from the audience here. 21

MS. MARTIN: Oh, this audience likes to 22

participate. For those that don't know me, I am 23

Melissa Martin, I just finished being president of the 24

AAPM. So, currently I guess I'm speaking as Chairman 25

44


of the Board of the AAPM. 1

But, the other thing I was just going to 2

reach out to you is, we start planning our AAPM 3

meetings literally one year in advance. We would love 4

to have a commitment from the NRC that you would 5

provide us a speaker because we can make a designated 6

time slot if we know in advance that we can have a 7

speaker. It's just we can't commit a slot, two months 8

up before the program because our program is literally 9

set at least from October before the next meeting in 10

July or August. 11

But we would definitely welcome the 12

opportunity to have a designated regulator session 13

meet with the regulator, have presentations. And we 14

could include a state or an OAS or NRC. 15

But if we can get a, basically an 16

agreement that the NRC would provide us a speaker, I 17

guarantee you the medical physicist would love the 18

opportunity to make that a designated slot in our 19

program each year. 20

CHAIRMAN ALDERSON: So when is your next 21

meeting? 22

MS. MARTIN: The fourth week of July. 23

CHAIRMAN ALDERSON: July. 24

MS. MARTIN: Of this year. It's always 25

45


basically the last week of July, first week of August. 1

CHAIRMAN ALDERSON: So you'd be thinking 2

now about having speakers for the meeting in July of 3

'19 or -- 4

MS. MARTIN: Correct. Because this year's 5

meeting is set. 6

CHAIRMAN ALDERSON: Well, I think that our 7

physics people on this Committee and the NRC should 8

work on that and see if you can make a guarantee that 9

will allow them to do that. 10

MR. BOLLOCK: Yes. So we are aware of the 11

meeting every July and so far we've been sending 12

actually two of my staff, Maryann or Katie. One or 13

both have attended the past few years and we continue 14

to strive for that. 15

Unfortunately, because our budget just 16

changed year to year and then when we can get 17

approvals for figuring out all the travel for not just 18

our group, the larger division as a whole, I don't 19

know that we can, unfortunately we can't make that 20

committee. 21

CHAIRMAN ALDERSON: All right. 22

MR. BOLLOCK: But I can't say that we can 23

-- 24

CHAIRMAN ALDERSON: Well, our members 25

46


should keep that in mind too. 1

MR. BOLLOCK: Right. 2

CHAIRMAN ALDERSON: And Sophie reminds me 3

that we do need to wrap it up here this morning 4

because -- 5

MS. MARTIN: Thank you. 6

CHAIRMAN ALDERSON: Thank you very much 7

for your comment. 8

MS. MARTIN: Yes. 9

CHAIRMAN ALDERSON: Because we do need to 10

get down to the Commission meeting. 11

MS. HOLIDAY: One more, very quickly. 12

CHAIRMAN ALDERSON: If this happens to be 13

a very brief comment. 14

MS. KUBLER: Sure. Hi, Caitlin Kubler 15

with the Society of Nuclear Medicine Molecular 16

Imagining. Our meeting is in Philadelphia this year, 17

hopefully that means it's a little bit easier. 18

I know Doctors Palestro and Metter had a 19

lot of questions last year after their session. So, 20

on behalf of SNMMI we would welcome the opportunity to 21

field questions. 22

We can advertise that on our website. We 23

are available and we would very much like to work with 24

the NRC to have that available. 25

47


CHAIRMAN ALDERSON: Thank you very much. 1

MR. BOLLOCK: Thank you. 2

CHAIRMAN ALDERSON: All right, I think 3

that will bring the morning session to an end and 4

we'll prepare now to meet with the Commission. Thanks 5

very much. 6

(Whereupon, the above-entitled matter went 7

off the record at 9:31 a.m. and resumed at 1:33 p.m.) 8

MEMBER ZANZONICO: Okay. So welcome back 9

everyone. 10

So, since Dr. Alderson has left to return 11

home, as my last official act on Committee, I'll be 12

moderating today's session. 13

And it's an open forum but it's going to 14

begin with a presentation by Lisa Dimmick on the need 15

for innovation and transformation. I think something 16

we can all agree on. So, Ms. Dimmick, it's all yours. 17

MS. DIMMICK: Thank you. Good afternoon, 18

everyone. So, I am here today in my typical job, or 19

my regular job at the NRC is, I'm the medical 20

radiation safety team leader, but I am currently on a 21

detailed assignment for three months on the NRC's 22

transformation team. So today I wanted to tell you 23

about this initiative here at NRC that we are in the 24

middle of. 25

48


So on January 4th the NRC Executive 1

Director for Operations, Vic McCree, issued a member 2

to all NRC staff on the importance of innovation and 3

transformation here at NRC. 4

And then on January 25th the EDO issued 5

the tasking memo to the transformation team. And the 6

transformation team was stood up on January 29th. 7

The team comprises 16 NRC staff members. 8

They were tasked to produce a SECY paper within 90 9

days of the tasking date to recommend areas of 10

transformation for the NRC. 11

So why the need for transformation, well, 12

industry has, industry is and industry will continue 13

to introduce new and novel technologies that challenge 14

our current regulatory framework. Such that this now 15

presents an opportunity for the NRC to become more 16

agile, efficient and effective in our regulatory 17

approach. 18

So, in this sense, transformation, what do 19

we mean by transformation, it's really, we're looking 20

at fulfilling or how we might fulfill our mission in a 21

different way under a different paradigm. So it's a 22

shift in our approach to regulation, our regulatory 23

approach. 24

So we were tasked to develop strategies 25

49


that would enhance and sustain a transformative 1

culture here at NRC. And also, to consider specific 2

areas of transformation that include digital 3

instruments and controls, accident tolerate fuels, new 4

materials and manufacturing methods, big data and 5

advanced reactors. 6

So while that seem might very reactor 7

centric, because that is the, I guess the bulk of NRC, 8

no other ideas that cross the agency are off the 9

table. So we, as the transformation team, we've 10

received lots of ideas from all areas of NRC. And 11

many of them are crosscutting type of ideas that 12

people have presented to the transformation team. 13

But regardless of the transformation that 14

might occur, NRC's mission does not change. Our 15

mission to protect the public health and safety says 16

and we're not changing the mission. That was one area 17

that was, you cannot transform the mission. That was 18

just in our tasking memo. 19

But even though, like I said, we're 20

looking, had specific areas that we were tasked, that 21

were being tasked to look at for transformation, we 22

are considering all ideas that are received. 23

So, at the moment we've basically have 24

completed our internal and external outreach. 25

50



MS. DIMMICK: So we have basically 2

completed our internal and out, external and internal 3

outreach. So internally we attended office and 4

division level meetings to present information on the 5

transformation team and also to solicit feedback from 6

NRC staff. 7

We have held informational meetings with 8

staff in these specific areas. We've interviewed 9

staff and we've had lots of information sessions 10

trying to get the message out to staff to provide 11

input to the transformation team. 12

Externally we've solicited some comments 13

from the nuclear industry, non-government 14

organizations, public organizations, private companies 15

and other federal agencies. Basically to benchmark 16

and leverage best practices and see where other 17

agencies may be undergoing the same initiatives that 18

the NRC is undertaking so that we can share best 19

practice or benchmark these activities as we move 20

forward. 21

We will be presenting our information at 22

the RIC next Tuesday afternoon. We'll be able to 23

discuss the feedback that was received, or has been 24

received, and the potential areas of transformation at 25

51


NRC. 1

So that's basically, I just wanted to 2

inform the group of this effort. There will be more 3

to come as we develop the SECY paper and then the 4

Commission votes or which direction this Commission 5

will go based on the recommendations. 6

And as we implement the transformative 7

ideas I'm certain ACMUI will be kept informed of any 8

changes that NRC is making in all areas of the 9

organization. And I think that was it. 10

So this was just a one-pager but we split 11

it up over the slide. So I think that was kind of 12

where they concluded. So it was more to inform and 13

that was it for today. 14

VICE CHAIRMAN ZANZONICO: Can I, will the 15

ACMUI have an opportunity to review the paper, the 16

SECY paper in draft form or -- 17

MS. DIMMICK: No, not on this one. This 18

one will, it will go through its concurrence process 19

and that's in part while we will be finalizing our 20

ideas after the RIC. 21

And then the paper will enter the 22

concurrence process and then go to the Commission on 23

this one. But once it's publicly, it will become 24

publicly available we can share the SECY paper. 25

52


MEMBER ENNIS: So, in terms of outreach -- 1

I don't think you reached out to us. 2

MS. DIMMICK: Correct. 3

MEMBER ENNIS: Unless I missed it. 4

MS. DIMMICK: So it was a -- it's a tight 5

timeline for the outreach. So there was some outreach 6

-- and we have some limitations on external outreach 7

that we can do with regard to a clearance. So we had 8

to stay within our limit of external outreach in that 9

-- in that sense. And the first public outreach, if 10

you will, will be the RIC next week. So this meeting 11

was before the RIC. 12

MEMBER ENNIS: What about the medical 13

constituents? 14

(Simultaneous speaking.) 15

MS. DIMMICK: Right. 16

MEMBER ENNIS: Besides us? 17

MS. DIMMICK: That -- so, there may be 18

additional information or outreach after, but again, 19

given the 90-day timeline and really having to 20

complete outreach within the first four weeks of the 21

effort -- four to six weeks of the effort -- there 22

wasn't an opportunity to do a public outreach in that 23

sense. 24

VICE CHAIRMAN ZANZONICO: Other questions 25

53


or comments? 1

MR. OUHIB: This is more or less sort of 2

an internal restructuring or - 3

MS. DIMMICK: Looking at our regulatory 4

approach -- so it's an -- it is. It's looking at how 5

we can transform our culture. So it's a big look at 6

our change management and our culture at NRC and how 7

we can -- what we can implement to make the culture 8

more transformative than what it has been in the past 9

in that sense. And then looking at specific areas 10

that -- where NRC has been challenged, specifically in 11

some of the reactor areas. Like digital instruments 12

and controls and accident-tolerant fuel. 13

MR. OUHIB: So just as a follow-up, what 14

actually triggered this effort? 15

MS. DIMMICK: I am not certain. It could 16

be -- I could speculate that it could be a number of 17

interactions and engagements from the public on 18

certain reactor areas. And looking -- identifying 19

that this might be a good time to really look at 20

ourselves and how we can innovate and transform. 21

MR. BOLLOCK: Yes, this is Doug Bollock. 22

It was a -- this is absolutely an NRC-driven action. 23

We weren't directed by Congress or, you know -- well, 24

Congress is really the only ones that can influence 25

54


the commission. But they weren't an influence at this 1

time, however there was a lot of stakeholder, public 2

and a little bit of congressional interest because 3

there -- some of the things that the commission had 4

been hearing were -- like, the digital I&C. The sort 5

of -- the power plants, they want to change out one of 6

their safety systems to -- from old analogue, you 7

know, 1960's, '70's technology to 1980's, 90's 8

technology that are newer. 9

And they had a lot of difficulty in doing 10

that. They don't have -- the reactor side and most of 11

our other regulations don't have a 35.1000. 12

Essentially. So there are -- there are regulatory 13

hurdles that they would have to overcome for -- to use 14

new technologies in a lot of -- in a lot of cases. So 15

this is looking at what flexibilities -- what -- how 16

can we transform to not get in the way of innovation? 17

Just because the digital I&C systems are new and 18

we're not used to it doesn't mean that they're not 19

safe -- and in some cases can have advantages and be -20

- have, you know, higher margin of safety for -- for 21

reactor safety and those aspects. 22

MS. DIMMICK: Thank you for pointing out 23

the 35.1000. I should have added that given the -- 24

the group. That's correct. Other areas of the 25

55


regulations don't have that type of regulation that 1

would allow a new technology to be evaluated so that 2

it could be licensed. Go ahead. 3

MR. GREEN: It sounds like a lot of the 4

input that you're receiving from staff and from the 5

group is reactor-centric. Do you -- do you know if 6

you've received any medical-related input? 7

MS. DIMMICK: I don't know that I've -- 8

that I'm not certain of -- if we have, specifically, 9

in that regard. We've received a lot of licensing 10

input that cross-cuts the agency for how to be more 11

efficient and effective with licensing. So just from 12

all aspects of the agency. 13

VICE CHAIRMAN ZANZONICO: Any other 14

questions or comments? 15

(No audible response.) 16

VICE CHAIRMAN ZANZONICO: Okay, hearing 17

none -- thank you very much. 18

MS. DIMMICK: Thank you very much for the 19

opportunity. 20

VICE CHAIRMAN ZANZONICO: So I think our 21

next and final order of business is Sophie -- Ms. 22

Sophie Holiday on the administrative close and follow-23

up of different items that were addressed from this 24

meeting. 25

56


MR. BOLLOCK: I should also explain that I 1

do -- with the issue I want to discuss, there is a 2

chance for open forum again at the end of the meeting. 3

So just a reminder -- 4

VICE CHAIRMAN ZANZONICO: Certainly. If 5

there's -- this action was part of this -- this 6

presentation was part of the open forum part of the 7

program. So if there are any other issues at all that 8

anyone would like to bring up, now is the opportunity. 9

MR. GREEN: Just kind of as a debrief from 10

the meeting with the Commissioners, I think they were 11

very open to the suggestions that were made by the 12

ACMUI and I like what I heard. I think we were given 13

the nod to go ahead and think through the projects and 14

develop the -- the thought processes and ways to -- 15

you know, measure competency. But I didn't hear any 16

no's. 17

VICE CHAIRMAN ZANZONICO: Any other issues 18

either related to the Commission briefing or 19

otherwise? Yes. 20

MEMBER ENNIS: Rob Ennis. I guess -- I 21

mean, along those lines. I guess the social culture, 22

subcommittees is now in a holding pattern until we 23

hear from the Commissioners? 24

MR. BOLLOCK: So, we -- 25

57


MEMBER ENNIS: Because we've made some 1

recommendations and staff feels like they can't do it 2

right now, essentially -- is what I understood. So -- 3

MR. BOLLOCK: Right, and then -- you know, 4

one of the Commissioners was very candid in -- in his 5

thoughts on the -- on the -- and very directly said 6

no. But that doesn't mean -- actually it's good that 7

you brought that out. There are a lot of things in 8

looking at the -- the report and what the intent of 9

what the ACMUI -- the ACMUI as a whole, the 10

subcommittee and then the entire community -- in 11

positive things to -- out of that -- out of that 12

subcommittee report. You know, education rather than 13

punitive for reporting medical events. And ways we 14

can improve that education. 15

As we discussed yesterday morning, some 16

things that we can -- we stack and work on, ensuring 17

the ACMUI's perspective on, you know, what you think 18

are the common hot topics -- I mean, we said not to 19

use the term hot topic, but the themes, I guess would 20

be -- could be a good -- good term. And we can share 21

-- you know, we can share that and pass along our 22

medical list server. 23

So actually that's -- open up the 24

committee, are there other ways besides -- I kind of 25

58


said this yesterday, you all shot -- shot for the moon 1

a little bit with -- with what you're saying, you 2

know. Whole -- wholesale changes, that's kind of hard 3

for us to do. But in the meantime, while the 4

commission is considering what was briefed to them, 5

you know, staff, we -- there are a lot of kind of the 6

easy fixes or little -- only takes a little bit of our 7

effort that may have some good ground towards, you 8

know, the end goal which -- or one of the end goals 9

that -- that I think we all agree on is the patient 10

safety in the safety culture. Right? We're all -- 11

we're all safety. I think we're all aligned, both 12

staff -- energy staff, the commission and the ACMUI, 13

in that goal. So I think there are things that we 14

could get out of that. So I can open that back up to 15

-- or, I guess, some of the other staff has some other 16

opinions. 17

DR. HOWE: I would just a like a 18

clarification, Doug, because Chairman Svinicki -- 19

COURT REPORTER: Please identify yourself. 20

DR. HOWE: This is Dr. Howe. Commissioner 21

Svinicki -- Chairman Svinicki and Barans -- she was 22

very careful in her wording because we only had two 23

Commissioners. 24

MR. BOLLOCK: Right. 25

59


DR. HOWE: So do we expect to get a staff 1

requirements memorandum or anything out of this 2

meeting? Or did she consider it more of a public 3

meeting and therefore we would not be tasked? 4

MR. BOLLOCK: I don't think it matters if 5

it's a public meeting or not. And -- so there is -- 6

there is always the option after this meeting if the 7

commission decides to task the staff with -- after 8

hearing from the committee, or the members of the 9

committee that presented -- to task the staff with 10

some work, either, you know, do that pilot that was 11

proposed or something -- anywhere in between based on 12

what -- what the commission decides amongst themselves 13

to have the task work on. And I -- Esther, do you 14

want add any? I saw your - 15

MS. HOUSEMAN: Yes, this is Esther 16

Houseman. I just want to point out that Commissioner 17

Baran and Chairman Svinicki made it clear that -- that 18

nothing was up for vote. And their comments in the 19

meeting did not constitute a vote on any proposals. 20

So this is certainly not a stop, pause, put this on 21

the shelf, don't proceed commentary from the 22

commission. They're simply letting you know their 23

preliminary thoughts based on the presentation before 24

them. And I should also point out, there was -- even 25

60


if they were to vote, they didn't have quorum, so they 1

couldn't anyway. So this should not affect your -- 2

your work and consideration in moving forward with 3

your recommendations based on the feedback that you've 4

received from the NRC staff. 5

MS. HOLIDAY: Additionally, I would like 6

to add -- this is Sophie -- I believe your question, 7

Dr. Ennis, is is the subcommittee in a holding 8

pattern? I would like to clarify that the 9

subcommittee had a specific charge. And as a result 10

of your charge you submitted a subcommittee report 11

which was voted on and unanimously endorsed by the 12

full Committee. So as such the subcommittee itself 13

has fulfilled its objectives. Now it is NRC staff's 14

turn to do something in response to the subcommittee's 15

-- or, the Committee's recommendations. 16

So the subcommittee itself -- there is no 17

active action going on. Not like Dr. Palestro's 18

Training and Experience Subcommittee. 19

MR. BOLLOCK: I would -- thank you, 20

Sophie. And thank you, Esther for clarifying that. I 21

appreciate that. But -- so I just open up to any 22

other dialogue that the committee would have on the 23

staff. And we've -- we've said this is -- it's a lot 24

for us to do all that. We don't think we can do 25

61


everything. But like I -- I just said earlier, there 1

are things that we can do. So maybe if you want to 2

continue further with that dialogue over the next few 3

minutes, we are open to that and it will help us in 4

taking any actions. 5

VICE CHAIRMAN ZANZONICO: So, the floor is 6

open. 7

MR. OUHIB: This is Zoubir. My impression 8

of that, there was -- there was a lot of 9

understanding, not necessarily agreeing or endorsing. 10

However, if there were -- there were some questions, 11

I thought, that it's almost like could you come up 12

with something? Or clarify? Or could provide a 13

little more details in this or in this or in that. 14

And I think maybe if we have access to the minutes 15

we'll be able to actually look at that and see. You 16

know, and I can't remember, but I think there might 17

have been one -- for you, Dr. Palestro. And if I 18

remember correctly -- there was almost like two items 19

that need some follow up or some work. That was my 20

recollection. 21

MEMBER PALESTRO: I think for the Training 22

and Experience Subcommittee, it was pretty clear what 23

we needed to do -- and it is to continue working 24

closely with staff to develop a program for 35.390. 25

62


MS. HOLIDAY: And just for your awareness, 1

Zoubir, minutes from the Commission meeting will be 2

available within 30 days -- similar to the ACMUI 3

meeting as well. And I will be happy to share that 4

with the committee. 5

VICE CHAIRMAN ZANZONICO: Anything 6

further? 7


VICE CHAIRMAN ZANZONICO: Let me just ask 9

you this question. You indicated with respect to 10

safety culture, medical event reporting, there were 11

things that staff can do. 12

MR. BOLLOCK: For instance -- 13

VICE CHAIRMAN ZANZONICO: For instance. 14

MR. BOLLOCK: Well, we discussed yesterday 15

with sharing the ACMUI's -- the ACMUI subcommittee, I 16

think they took it -- I took it on that you would give 17

it a -- kind of, the ACMUI's subcommittee's thoughts 18

on any themes and events in helping the education, 19

sharing of that information for with the -- the 20

medical community. And then we can -- we can take 21

that and not just put it on our website, but share it 22

in the medical list server and share the -- I don't 23

think Sophie's pointing out that she wrote that -- did 24

you write that down, Sophie? 25

63


MS. HOLIDAY: I did. I took it as an 1

action item. 2

MR. BOLLOCK: So we've taken it as an 3

action item as you -- as you can see. So we will -- 4

you know, we will -- yes, I don't know that -- 5

specifically the ACMUI's actions on the medical 6

events. Yes, there it is. I'm reading -- sorry, I'm 7

reading top to bottom. So we will take that on as an 8

action, share that as best we can. Are there any 9

other things similar to that? I know we've said we 10

are going to take a look at our Management Directive 11

810, which is what sets the -- our response to medical 12

events. Right, this is what -- that determines if 13

it's a medical event over 20 percent, we send in a 14

reactive inspection team within five days. We are 15

considering -- so, for that we are considering the 16

ACMUI's comments while staff goes through. It's just 17

-- it's a normal revision cycle, but we will take that 18

in consideration. And, you know, I can't promise we 19

are going to make any changes. We haven't started 20

looking at it. But, you know, there is potential 21

there that we can consider kind of -- perhaps consider 22

the graded -- a more graded approach. Like I said, I 23

can't say that we're not going to react in some way. 24

But perhaps -- give some flexibility a little bit more 25

64


thought, case-by-case, and, you know, we will at least 1

consider all that. 2

VICE CHAIRMAN ZANZONICO: Dr. Metter, did 3

you have a comment? 4

MEMBER METTER: I was wondering, I noticed 5

that when the different -- shows for the 6

subcommittees, the different individuals presented to 7

the commissioners, there was some -- these were -- 8

these slides were sent before with the reports and all 9

that. I was wondering if they could be sent maybe a 10

little earlier so in case there is a little discussion 11

-- because I think there was a little concern about 12

some changes, perhaps, before -- from the time that 13

they were submitted till the time that it was 14

presented. Maybe Dr. Palestro can explain. 15

MEMBER PALESTRO: Yes, I thought the 16

preparatory session was excellent. I think they're 17

always very good. And just a couple things. Number 18

one, I think that we should, to the extent that we 19

can, incorporate questions that might be anticipated -20

- that you would anticipate the commission is going to 21

ask because that's always helpful to be prepared for 22

something like that. And I've found it useful. But I 23

think that if given the opportunity all of us probably 24

would have made some changes to our slides. So the 25

65


question arises -- I was wondering if rather than 1

reviewing those -- those presentations the day before 2

meeting with the commission, if they could be reviewed 3

sufficiently in advance either by the entire committee 4

via telephone conference, or by the chair and vice 5

chair? Or some -- some method of review so that we do 6

have time to make changes. 7

MS. HOLIDAY: Sure. Well, I can tell you 8

that NRC has a procedurally -- per procedures that are 9

set by the Office of the Secretary, presentation 10

slides for Commission meetings are to be submitted no 11

later than five business days prior to Commission 12

meeting. So these had to be submitted by last 13

Thursday on March 1st. So with that being said, of 14

course the preparatory session that we had yesterday 15

afternoon, of course, is significantly past that 16

deadline. 17

MEMBER PALESTRO: Correct. 18

MS. HOLIDAY: The only thing that I will 19

have to double check on is -- because the preparatory 20

session -- per fact of regulations, preparatory work 21

sessions amongst the Committee -- that is, you are 22

preparing for a meeting -- does not have to be noticed 23

in the Federal Register. But if there is going to be 24

a vote, if there is deliberation -- that is where we 25

66


start getting into the infringement of not being open 1

and transparent, which per fact of regulations means 2

it then has to be become an open, public meeting. So 3

we will have to be very careful about that. But I do 4

accept the committee's feedback and let me go back and 5

check to make sure that we won't be in violation of 6

any privacy concerns or non-transparency or -- or the 7

Sunshine Act. 8

MEMBER PALESTRO: Understood. I mean, 9

certainly there were no votes yesterday. And I don't 10

remember any preparatory sessions that we've actually 11

held a vote. It's basically reviewing and -- and 12

making suggestions amongst ourselves. And really what 13

I see is it's kind of an informal way. But, if it 14

works, that would be great. And if it doesn't, it 15

doesn't. 16

MR. BOLLOCK: Okay, I think -- this is 17

Doug Bollock. We will -- we will check on that. I 18

think there's the flexibility to do that. We'll just 19

have to -- Sophie and I just have to verify that we're 20

not -- doing -- violating any back up the ladder that 21

-- 22

MS. HOLIDAY: Additionally that means that 23

we would -- the Committee would have to be sure that 24

you've prepared the presentation slides earlier so 25

67


that we could have section meeting if that were to 1

occur. 2

MR. BOLLOCK: Yes, that's the -- I was 3

going to bring that up, the other -- 4


MS. HOLIDAY: There are a lot of time 6

constraints with meeting time around, of course. So. 7

MEMBER PALESTRO: But that would be -- 8

that would be established in advance. Something that 9

we -- we -- I imagine you could have resolved for us 10

by the full meeting, wouldn't you say? Whatever our 11

next commission meeting is, this is the deadline by 12

which -- or, the initial deadline for slide 13

submission. 14

MS. HOLIDAY: Absolutely. 15

VICE CHAIRMAN ZANZONICO: Mr. Green? 16

MR. GREEN: Yes, the question is for Mr. 17

Bollock. You know, there -- you're asking if there's 18

simple things that the staff can do that are not 19

massive changes. I know there's the medical event 20

reporting requirements, but I thought we established 21

that it's no requirement that you published the name 22

of the licensee on the website. Can we anonymize 23

things within your own power that's not against any 24

regulation? 25

68


MS. HOUSEMAN: This is Esther Houseman. 1

One requirement that we do have to keep in the back of 2

our minds, it's a bare bones statutory requirement, is 3

the requirement for abnormal occurrence reporting 4

which requires that the location of the facility at 5

which the abnormal occurrence occurs be reported to 6

Congress. We have reported location from certain 7

agreement states that simply say a facility in the 8

State of New York, a facility in the State of Texas 9

because we are respecting certain laws that they're 10

following with respect to confidential reporting. OGC 11

would have to advise the staff on whether they could 12

also similarly, to some degree, anonymize the facility 13

name and location in our reporting requirements. Just 14

wanted to point that out that that's a bare -- a bare 15

minimum requirement that in some way we have to 16

identify the location of the AO -- 17


MR. GREEN: I think if -- 19

MS. HOUSEMAN: Reports. 20

MR. GREEN: I'd love to have you research 21

those regulations and check with -- with the folks you 22

mentioned. If it could be just a facility in Albany, 23

New York that doesn't name the site, I think that's 24

going towards the less appearance of punitive and more 25

69


appearance of hey, report what happens. Let's learn 1

from other people's mistakes so we don't repeat them 2

at our facilities. 3

MS. HOUSEMAN: And OGC can certainly 4

advise the NRC staff on that question. And then it's 5

within the staff's purview to decide as a policy 6

matter whether that would be appropriate. 7

MR. BOLLOCK: Right, we can -- we can take 8

that as an action item to look into that. It's going 9

to take some coordination from us and the -- the other 10

offices that actually take in all the reporting. But 11

we will -- we can definitely look into that. It will 12

-- it won't change the fact that -- what the licensee 13

reports to us, they have to -- I mean, that is in the 14

regulation what -- right -- but what, what is shared 15

on the public website, yes, we can -- we can look into 16

what -- what we can do with that. 17

VICE CHAIRMAN ZANZONICO: Okay, further 18

discussion of any -- any relevant matter? Dr. Metter? 19

MEMBER METTER: I'd like perhaps, once a 20

year -- maybe in the fall -- for the different 21

committee members that have presented for -- like, 22

speak to the regulator sessions and just give an 23

update of what's happened on the -- with our different 24

society since we are looking at our external 25

70


stakeholders. 1

MS. HOLIDAY: That would be an ACMUI 2

action. So I guess -- this is Darlene's motion. 3

MEMBER ZANZONICO: Do -- do we need a 4

motion? So that -- the motion would be for once a 5

year for the ACMUI membership to report on their 6

outreach activities to professional societies? 7

MEMBER METTER: Correct. Correct. 8

VICE CHAIRMAN ZANZONICO: Okay. Well 9

that's -- there's a motion. 10

MEMBER PALESTRO: Second. 11

VICE CHAIRMAN ZANZONICO: Okay. All in 12

favor? 13

(Chorus of aye.) 14

VICE CHAIRMAN ZANZONICO: Okay, any nays? 15


VICE CHAIRMAN ZANZONICO: It's unanimously 17

approved. Anything further? 18


VICE CHAIRMAN ZANZONICO: It's getting 20

awfully echoey in here. 21

(Laughter.) 22


none, I think that it is Sophie's turn to go through 24

ACMUI recommendations and action items growing out of 25

71


this meeting. 1

MS. HOLIDAY: Yes, thank you. So this is 2

the other half of the administrative closing portion 3

of the meeting where we review any recommendations or 4

actions that came as a result of our two-day ACMUI 5

meeting. The first is that -- this is an NRC action -6

- that the NRC staff will post the full ACMUI 7

recommendations and action charts on the ACMUI public 8

web page. That is the charts from 2007 to present. 9

This was as a result of the request to capture past 10

historical committee recommendations to help future 11

committee members as well. So I have that as an open 12

indefinitely item. 13

Item seven -- I took after hearing the 14

conversation yesterday that NRC staff will send out a 15

medical list server announcement to inform their 16

subscribers of the availability of ACMUI and NRC 17

medical event slides each time that they are posted on 18

the medical toolkit. The reason I took this as an 19

action item is that there was a request or a need to 20

better inform and educate the medical community. So 21

each time Dr. Ennis's subcommittee completes their 22

presentations, his slides are put onto the medical 23

toolkit. After Donna-Beth -- Dr. Donna-Beth Howe 24

completes her presentation they also go on the medical 25

72


toolkit. However, no formal announcement is actually 1

sent out to inform people that those slides are there. 2

We just assume people will stumble upon them. So we 3

received the feedback that the committee provided 4

yesterday, and this is an NRC action open 5

indefinitely. 6

Item number eight was this morning the 7

committee tentatively planned to hold its fall meeting 8

on September 20th, 21st, 2018 with the backup date of 9

September 17th and 18th. The last item, which is not 10

on there -- which the committee just voted on -- is 11

that the committee will have a standing presentation 12

to be discussed at each ACMUI fall meeting for the 13

committee members to report back on their outreach to 14

their respective professional societal organizations. 15

Are there any questions or comments concerning these 16

four additional recommendations and actions from this 17

meeting? 18

VICE CHAIRMAN ZANZONICO: This is Pat 19

Zanzonico. I have a question about number seven. I -20

- other than purely information, since the -- any 21

subcommittee slides are -- are just that, 22

recommendations which ultimately may or may not be 23

adopted -- what's the implication or -- or purpose of 24

doing that? In that there are many slides for many 25

73


subcommittees presented at the various meetings. I 1

presume since these are public meetings, they're all 2

publically available. 3

MS. HOLIDAY: They are. 4

VICE CHAIRMAN ZANZONICO: So what's the 5

special status of -- of including the any subcommittee 6

slides in this additional posting? 7

MS. HOLIDAY: So, staff created a section 8

on its medical use licensee toolkit probably about two 9

-- two or three years ago to explain to any users -- 10

or any individuals that come across medical toolkit -- 11

what the purpose of the medical event reporting is. 12

In addition, there are links to the presentations that 13

the ACMUI has provided on their review of medical 14

events for that, you know, particular fiscal year and 15

NRC staff's review of the same medical events for the 16

fiscal year. So these are just ways to inform members 17

of the public about why NRC requires medical event 18

reporting and here are the medical events that are 19

reported to the NRC. And the committees reveal those 20

events from that perspective. 21

VICE CHAIRMAN ZANZONICO: Oh, okay. 22

MS. HOLIDAY: Does that help? 23

VICE CHAIRMAN ZANZONICO: So, I was 24

misunderstanding, I think -- and correct me if I am 25

74


wrong. When you -- what's going to be posted is the 1

medical event reporting items, not the medical event 2

or safety culture subcommittee slides? 3

MS. HOLIDAY: No, no, no, no. 4

VICE CHAIRMAN ZANZONICO: Oh, that's what 5

I - 6


MS. HOLIDAY: I am so sorry if I -- if I 8

was not clear. 9


VICE CHAIRMAN ZANZONICO: No, that was my 11

mistake, right. 12

MR. BOLLOCK: Right, yes. 13

MS. HOLIDAY: All of the -- all of the 14

subcommittee reports are on the subcommittee reports 15

web page. 16

VICE CHAIRMAN ZANZONICO: Fine. 17

MS. HOLIDAY: All of the slides for the 18

meeting are on the meetings' web page. But those are 19

all on ACMUI web pages. On the medical toolkit 20

there's a link specifically for medical events. 21

VICE CHAIRMAN ZANZONICO: Understood. I 22

misunderstood. 23

MR. BOLLOCK: Yes, we simply -- we pull 24

out those slides specific to that presentation and put 25

75


it in a -- in another spot -- 1

VICE CHAIRMAN ZANZONICO: Understood. 2

MR. BOLLOCK: Like Sophie just described, 3

yes. 4

MS. HOLIDAY: So are there any additional 5

questions or comments on our recommendations and 6

actions from this meeting? 7

VICE CHAIRMAN ZANZONICO: Darlene? Dr. 8

Metter? 9

MEMBER METTER: So, I like the idea of the 10

medical events reporting. I was wondering if there is 11

somehow a way that you could look at, like, every five 12

to ten years and look at the -- the spectrum? Because 13

I think what we've seen from going through the reports 14

that we had is that Y-90 is a huge part of this. And 15

perhaps the make the users aware about the issues -- 16

and mainly it's, like, I look at human error, time out 17

-- those are the major things. And maybe somehow 18

there could be a little summary. But I don't know if 19

you can put that on the website. Do you know what I 20

mean? 21

MS. HOLIDAY: Do you mean a summary of - 22

MEMBER METTER: Of, like, the -- you know, 23

issues that -- you know, 60 percent -- or, not would 24

cause -- but, 60 percent of the medical events of the 25

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last five years have been this mainly -- a major 1

concern would -- a major source of perhaps these 2

events were time out -- you know, these -- attending 3

to time out and maybe catheter. You know, certain 4

things. You know, just maybe one or two things that 5

maybe the user could go back and say, okay, let's be 6

careful about this and be sure time outs are done 7

correctly. And that everybody in the room knows 8

what's going on. That's just -- just as an 9

information thing for the user. And I -- I don't know 10

if you can do that, though. 11

MS. HOLIDAY: So, NRC, we have what we 12

call generic communications. When NRC staff 13

identifies that there are certain trends that are 14

happening -- such as if we, we find that there are a 15

lot of events that are reported due to lack of time 16

out procedure, or, you know, kinks or what -- what 17

have you. NRC staff can issue generic communications 18

specifically for that. I know there was one a couple 19

years ago related to HDR and the software. So we have 20

done stuff like that. 21

I have provided a five-year trend analysis 22

to the committee maybe a year or so ago. And I am 23

happy to do that going forward each year prior to Dr. 24

Ennis's subcommittee doing their presentation. 25

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Similar to how Dr. Howe, when she does her 1

presentation, she reiterates how many medical events 2

were reported in the previous years. We just 3

consolidate it into one document. Dr. Ennis? 4

MEMBER ENNIS: Yes, I think what you're 5

looking for is what I kind of anticipate the 6

subcommittee now doing. As -- based on our 7

conversations yesterday, I think we're not going to 8

recapitulate or slightly variation -- what -- what the 9

time frame that's looking at what Donna-Beth has done, 10

but rather actually try and do what you just alluded 11

to, some of the themes, concepts that are repeated 12

year after year after year. And then propose some way 13

of getting that information out to the community. 14

CHAIR ZANZONICO: Yes? 15

MS. SHOBER: This is Megan Shober. And I 16

think, Dr. Metter, that some of the information that 17

you're interested in is captured already in the NMED 18

annual reports. And those are publically available. 19

So there's -- there are, like, historical bar graphs 20

with different types of events, I am pretty sure. And 21

then, for the medical events there's also like a 22

really brief -- like, a two-sentence or three-sentence 23

summary for a lot of those medical events. 24

MEMBER METTER: I think I like the idea, 25

78


though, of including in Dr. Ennis's report because I 1

think that's more -- I mean, we're seeing it. We're 2

not attuned to what you're looking at. So I think the 3

people who are involved with the audience for this 4

actual meeting would be -- and if these slides are 5

available on the website, then I think that they'd be 6

more available to the people that are interested at 7

this point in time. 8

MR. BOLLOCK: Yes, I can talk a little bit 9

more to what Megan was talking about. The NMED Annual 10

Report does have that, but its' for -- I think it 11

actually has it for all materials events. But we do 12

break it down by category, and medical events are one 13

them. And it will have the trends for the previous -- 14

or, for, like, five-year trends. Whether it's the -- 15

and it -- but it just -- most of those are trending 16

numbers up and down. 17

Also, we -- but we do look for trends in, 18

you know, generic -- potential generic issue or -- I 19

guess if there was repeat causes. We do look for 20

that. And -- and like, we look at that for all 21

materials events. But we do -- you know, part of that 22

is -- is medical events. So we don't -- we do that on 23

a -- on a broad scale all the time. But I think it 24

would be helpful to us -- and I think, as a medical 25

79


community, if the ACMUI has your perspective on that 1

information. That's -- that's appreciated. I mean, 2

we do -- staff does look at that. We do look for 3

trends. And again, sometimes what we think is not a 4

big deal or necessarily a trend -- that's enough for 5

us to take a lot of action. You may think otherwise 6

and, you know, obviously you have the experience and 7

the clinical expertise to help inform us what should 8

be passed along to the medical community. So we would 9

appreciate that. 10

VICE CHAIRMAN ZANZONICO: Dr. Palestro? 11

MEMBER PALESTRO: Yes, I was just going to 12

say that my impression from yesterday's discussions 13

was the same as Dr. Ennis -- that the focus of the 14

subcommittee was going to change from essentially 15

repeating what Donna-Beth had on its cover to really 16

more of an analysis of the data. And in terms of 17

trends, I don't know how easy it is to access the data 18

going back five years to identify trends, but if the 19

subcommittee does this on a yearly basis, well five 20

years from now we'll be able to go back -- or, you'll 21

be able to go back and look and say this is what we've 22

seen over the past x-number of years. And then once 23

again, as Laura has pointed out, things that we need 24

to have. That creates the institutional history for 25

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the future. And I really think that the subcommittee 1

is probably the group best suited to put that together 2

because they're part of the ACMUI and they know what 3

all of us really are interested in seeing. And 4

hopefully the staff will -- you know, it will benefit 5

the staff as well. So I think that would be -- and 6

this has come up repeatedly over the years I've been 7

on the committee as to why have we been having 8

essentially the same review twice a year? And I think 9

it's a much better focus to -- to have the -- the 10

numeric data, if you will, presented by Donna-Beth -- 11

Dr. Howe at the beginning. Or, at the spring meeting, 12

at the fall meeting, an analysis of the data. 13

VICE CHAIRMAN ZANZONICO: Other comments, 14

questions? 15



none, I think we are adjourned then. Thank you all 18

and safe travels. 19

(Whereupon, the above-entitled matter went 20

off the record at 2:15 p.m.) 21

official transcript of proceedings nuclear regulatory ... · 3 appreciation. 4 vice chairman...

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